BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD GLUCOSE METER

    MDR report key: 19808318 · Received July 23, 2024

    Report

    Report Number
    3011196194-2024-00036
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    June 24, 2024
    Report Date
    July 23, 2024
    Manufacturer
    TELADOC HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K133584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR THE INVESTIGATION. SHOULD THE DEVICE BE RETURNED AT A LATER DATE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE PATIENT STATED THAT THEY SOUGHT MEDICAL ATTENTION AT HOSPITAL DUE TO RECEIVING A READING OF 27 FROM THE LIVONGO BLOOD GLUCOSE METER AND EXPERIEINCING SYMPTOMS OF DIZZINESS. THE PATIENT ADVISED THAT THEY WERE GIVING FLUIDS FROM AN IV AT THE HOSPITAL AS TREATMENT. THEY ALSO CONFIRMED THAT THEY BROUGHT THE LIVONGO METER TO THE HOSPITAL TO COMPARE READINGS. THE READING FROM THE HOSPITAL WAS 130 COMPARED TO THE LIVONGO METER READING 116. OUR INVESTIGATION FOUND THAT THE PATIENT WAS TESTING WITH EXPIRED TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964074 LIVONGO BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW TELADOC HEALTH INC BG300C

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown Hospitalization